Regulatory Updates

Distribution date: 25 April 2022 | Final date for Comment: 17 June 2022

Notice of proposed rulemaking - FRA proposes to amend its Safety Glazing Standards for exterior windows on railroad equipment to codify long-standing waivers, add a new testing option to improve consistency of glazing testing, and revise outdated section headings. The proposed changes would update and clarify existing requirements to maintain and, in some cases, enhance safety, while reducing unnecessary costs. Codification of the waivers as proposed is also consistent with the Infrastructure Investment and Jobs Act, and would enable FRA to more efficiently use its inspection resources.

Products Covered: Safety glazing standards; Prepared pigments, prepared opacifiers and prepared colours, vitrifiable enamels and glazes, engobes, liquid lustres and similar preparations of a kind used in the ceramic, enamelling or glass industry; glass frit and other glass in the form of powder, granules or flakes (HS code(s): 3207); Quality (ICS code(s): 03.120); Test conditions and procedures in general (ICS code(s): 19.020); Railway rolling stock in general (ICS code(s): 45.060.01); Glass (ICS code(s): 81.040)

Regulation Type: Regular notification

Distribution date: 25 April 2022 | Final date for Comment: 24 June 2022

The text revises the part of the EU specifications of food additives related to ethylene oxide. Currently, Regulation (EU) No 231/2012 provides that ethylene oxide may not be used for sterilizing purposes in food additives. However, there is no quantified limit for the presence of ethylene oxide regarding all food additives. Recently, in the European Union, there have been several notifications concerning findings of ethylene oxide in particular in a number of food additives used for the manufacture of a variety of foodstuffs. However, it is difficult to establish whether the presence of ethylene oxide results from its use in the sterilization of the food additives in breach of Regulation No 231/2012 or from any other reason.In order to avoid those difficulties and to ensure a high level of protection of human health, it is therefore appropriate to lay down that the presence of ethylene oxide, irrespective of its origin, is not authorized for all food additives. For this purpose, a maximum limit for residues of ethylene oxide specific for food additives should be set out at the limit of quantification in those products, that is, at the validated lowest residue concentration, which can be currently quantified and reported by routine monitoring with validated control methods. This corresponds to maximum limit of 0.1 mg/kg of ethylene oxide (sum of ethylene oxide and 2-chloro-ethanol expressed as ethylene oxide) applicable to all authorized food additives.

Products Covered: Food products

Regulation Type: Regular notification

Distribution date: 25 April 2022 | Final date for Comment: 24 June 2022

The text revises the part of the EU specifications of food additives related to ethylene oxide. Currently, Regulation (EU) No 231/2012 provides that ethylene oxide may not be used for sterilizing purposes in food additives. However, there is no quantified limit for the presence of ethylene oxide regarding all food additives. Recently, in the European Union, there have been several notifications concerning findings of ethylene oxide in particular in a number of food additives used for the manufacture of a variety of foodstuffs. However, it is difficult to establish whether the presence of ethylene oxide results from its use in the sterilization of the food additives in breach of Regulation No 231/2012 or from any other reason.In order to avoid those difficulties and to ensure a high level of protection of human health, it is therefore appropriate to lay down that the presence of ethylene oxide, irrespective of its origin, is not authorized for all food additives. For this purpose, a maximum limit for residues of ethylene oxide specific for food additives should be set out at the limit of quantification in those products, that is, at the validated lowest residue concentration, which can be currently quantified and reported by routine monitoring with validated control methods. This corresponds to maximum limit of 0.1 mg/kg of ethylene oxide (sum of ethylene oxide and 2-chloro-ethanol expressed as ethylene oxide) applicable to all authorized food additives.

Products Covered: Food products

Regulation Type: Regular notification

Distribution date: 19 April 2022 | Final date for Comment: 18 June 2022

To reinforce post marketing safety management and streamline submission of use of investigational products for treatment purpose by establishing legal basis on order to change of submission deadline of pharmaceutical risk management plan and on safety and efficacy review results. And to ensure patients' safety in using the investigational products by obligating investigational products providers to manage the safety information.

Products Covered: Pharmaceuticals

Regulation Type: Regular notification

Distribution date: 19 April 2022 | Final date for Comment: 18 June 2022

To reinforce post marketing safety management and streamline submission of use of investigational products for treatment purpose by establishing legal basis on order to change of submission deadline of pharmaceutical risk management plan and on safety and efficacy review results. And to ensure patients' safety in using the investigational products by obligating investigational products providers to manage the safety information.

Products Covered: Pharmaceuticals

Regulation Type: Regular notification

Distribution date: 19 April 2022

This addendum concerns the notification of the Ministerial Decree No. 195/2022 (3 pages, in Arabic) amending the rules governing the registration of Factories eligible to export their products to the Arab Republic of Egypt as follows:The third paragraph of Article (1) of Ministerial Decree No. 43 of 2016 is repealed.Paragraph 3 of Article (2) of Ministerial Decree No. 43 of 2016 shall be replaced by the following paragraph:“Registration in the registry(register)  referred to in Article (1) of  Decree 43/2016 occurs as soon as the required documents are submitted and fulfilled; the relevant applicant (on behalf factory or company )shall receive a proof of registration within a period of no longer than 15 days. In case of suspicion in the validity of the submitted documents, registration in the relevant registry will not take place until these documents have been verified. Based on a  request  from  the  applicant,  inspection  of  the  company  or  manufacturing  plant  may  take   place  to  verify  the  validity  of  the  documents  after  obtaining  the  approval  of  the  Minister  of   Foreign Trade”.Paragraphs 4, 5 and 6 will be added to Article 2 of Decree 43 of 2016,  and two new articles  will be added Article 2(bis ) and Article 2(bis1 )  as follows:Paragraph 4: Documents for registration may be submitted through the embassies or consulates of the governments of the relevant countries.Paragraph 5: Documents that have an expiry date shall be renewed within a period not exceeding 30 days from the date of expiry.Paragraph 6: Companies/factories  registered or cancelled from the registry  shall be published monthly in the Egyptian Gazette and on GOEIC’s website. Article 2(bis)Striking off /cancelling of registration shall take place through a decision by the head of GOEIC and the decision will state the reasons for cancellation of the registration. A grievance of the cancellation decision may be submitted within 60 days of informing the relevant factory /company to the grievance committee established as per Article 2 (bis1) of this decree. Article 2(bis1)A grievance committee shall be established by a Decree of the Minister of Trade and Industry, to follow grievances against non-registration or cancelling of registration, and the grievance request shall be submitted to the Trade Agreements and Foreign Trade Sector. The grievance shall be decided upon within a period not exceeding 15 days from the date of its submission, and the grievant shall be informed of the reasons of non-registration or cancelling of registration and the corrective actions that must be taken to re-register. Date of adoption: 29 March 2022Date of entry into force: 1 April 2022.Agency or authority designated to handle comments and text available from:Trade Agreements and Foreign Trade SectorMinistry of Trade and IndustryEmtedad Ramses St., Nasr City, Cairo- EgyptEmail: [email protected]: www.tas.gov.egTel.: + 20 (2) 23421950Fax: + 20 (2) 23421946 National Enquiry Point Egyptian Organization for Standardization and Quality16 Tadreeb El-Modarrebeen St., Ameriya, Cairo - EgyptE-mail: [email protected]/[email protected]: http://www.eos.org.egTel: + (202) 22845528 - Fax: + (202) 22845504

Products Covered: • Milk and milk products (except for infants' milk) for retail sale in packages weighing no more than 2 kilograms (Products of HS codes from 04.01 to 04.06) ; • Preserved and dried fruits for retail sale in packages weighing no more than 2 kilograms (Products of HS Chapter 08) ; • Oils and fats for retail sale in packages weighing no more than 5 kilograms (Products of HS chapter 15) ; • Chocolates and food products containing cocoa for retail sale in packages weighing no more than 2 kilograms (Products of HS code 18.06) ; • Sugar confectionaries (HS code 17.04) ; • Pastas and prepared foods from cereals and bread products and pastries except for empty cachets of a kind suitable for pharmaceutical use (HS codes 19.02-19.04-19.05) ; • Fruit juices for retail sale in packages weighing less than 10 kilograms (Products of HS code 20.09) ; • Natural and mineral water and aerated water (HS codes 22.01-22.02) ; • Beauty and make-up products, preparations for oral or dental hygiene, personal deodorants and antiperspirants, and perfumed preparations (HS codes from 33.03 to 33.07 ) ; • Soap and washing preparations used as soap for retail sale (HS 3401.11 – 3401.19 – 3401.2090 – 3401.30 - 3402.20 – 3402.9090) ; • Cutlery and kitchen utensils (HS codes 39.24 - 4419 – 69.11 – 6912 – 73.23 – 7418.10 – 7615.10 – 8211.10 - 8211.91 - 82.15) ; • Baths, shower baths, sinks, washbasins, bidets, lavatory pans, seats and covers ; • Toilet Paper and similar paper, babies and sanitary napkins (HS codes 9619 –48.18 (except for 4818.1090 ) – 4803) ; • Refractory bricks, blocks, tiles for household use (HS codes 6802.10 – 6802.2110 – 6802.9110 – 6904.40 - 6810.19 – 69.07 – 69.08) ; • Tableware glass articles (HS code 70.13) ; • Iron and steel bars and rods (HS codes 72.13 – 72.14 – 72.15) ; • Household electrical appliances (stoves, fryers, air conditioners, fans, washing machines, blenders and heaters) (Products of HS codes 73.21 – 73.22 – 8414.51 - 8415.10 8415.81 - 8415.82 – 8415.83 – 8418.10 – 8418.21 – 8418.29 – 8418.30 – 8418.40 – 8422.11 – 8450.11 – 8450.12 – 8450.19 – 8451.21 – 8508.11 – 8509.40 – 8509.80 – 8516.10 – 8516.21 – 8516.32 – 8516.40 – 8516.50 – 8516.60 – 8516.71 – 8516.72 – 8516.79 – 8527.12 – 8527.13 – 8527.19 – 8527.91 – 8527.92 – 8527.99 – 8528.71 – 8528.7220 – 8528.7290 – 8528.73) ; • Home and Office furniture (HS codes 9401.30 – 9401.40 – 9401.51 – 9401.59 – 9401.61 – 9401.69 – 9401.7190 – 9401.79 - 9401.8090 - 94.03 – 94.04 ) ; • Bicycles, motorcycles and those with auxiliary motors (HS codes 87.11 – 8712) ; • Watches and clocks (Products of HS chapter 91) ; • Lightening equipment for household use (HS codes9405.10 – 9405.20 – 9405.30 - 9405.4090) ; • Toys (HS code 9503) ; • Textiles, clothing, and home textiles (HS chapters and codes: 50.07 – 51.11 – 51.12 – 5113 – 52.08 - 52.09 – 52.10 – 52.11 – 52.12 – 53.09 – 5311 - 54.07 – 54.08 – 55.12 – 55.13 – 55.14 – 55.15 – 55.16 – 58.01 – 58.02 – 58.04 – 58.05 – 58.09 - 5810.1090 – 5810.91 – 5810.92 – 5810.99 , Chapter 60 , Chapter 61 (except 6113.0010 6114.3010 – 6115.10 – 6116.1010), Chapter 62 (except 6210.1010 - 6210.2010 – 6210.3010 – 6210.4010 – 6210.5010 - 6211.3910 – 6211.4910 – 6212.2010 – 6212.9010 – 6216.0010 – 62.17), Chapter 63 (except for 63.07) ; • Carpets , floor and wall coverings from textiles or non- textiles materials (HS chapter 57, HS codes 39.18, 4016.91) ; • Footwear (HS codes 64.01 – 64.02 – 64.03 – 64.04 – 64.05)

Regulation Type: Addendum to Regular Notification

Distribution date: 19 April 2022

This addendum concerns the notification of the Ministerial Decree No. 195/2022 (3 pages, in Arabic) amending the rules governing the registration of Factories eligible to export their products to the Arab Republic of Egypt as follows:The third paragraph of Article (1) of Ministerial Decree No. 43 of 2016 is repealed.Paragraph 3 of Article (2) of Ministerial Decree No. 43 of 2016 shall be replaced by the following paragraph:“Registration in the registry(register)  referred to in Article (1) of  Decree 43/2016 occurs as soon as the required documents are submitted and fulfilled; the relevant applicant (on behalf factory or company )shall receive a proof of registration within a period of no longer than 15 days. In case of suspicion in the validity of the submitted documents, registration in the relevant registry will not take place until these documents have been verified. Based on a  request  from  the  applicant,  inspection  of  the  company  or  manufacturing  plant  may  take   place  to  verify  the  validity  of  the  documents  after  obtaining  the  approval  of  the  Minister  of   Foreign Trade”.Paragraphs 4, 5 and 6 will be added to Article 2 of Decree 43 of 2016,  and two new articles  will be added Article 2(bis ) and Article 2(bis1 )  as follows:Paragraph 4: Documents for registration may be submitted through the embassies or consulates of the governments of the relevant countries.Paragraph 5: Documents that have an expiry date shall be renewed within a period not exceeding 30 days from the date of expiry.Paragraph 6: Companies/factories  registered or cancelled from the registry  shall be published monthly in the Egyptian Gazette and on GOEIC’s website. Article 2(bis)Striking off /cancelling of registration shall take place through a decision by the head of GOEIC and the decision will state the reasons for cancellation of the registration. A grievance of the cancellation decision may be submitted within 60 days of informing the relevant factory /company to the grievance committee established as per Article 2 (bis1) of this decree. Article 2(bis1)A grievance committee shall be established by a Decree of the Minister of Trade and Industry, to follow grievances against non-registration or cancelling of registration, and the grievance request shall be submitted to the Trade Agreements and Foreign Trade Sector. The grievance shall be decided upon within a period not exceeding 15 days from the date of its submission, and the grievant shall be informed of the reasons of non-registration or cancelling of registration and the corrective actions that must be taken to re-register. Date of adoption: 29 March 2022Date of entry into force: 1 April 2022.Agency or authority designated to handle comments and text available from:Trade Agreements and Foreign Trade SectorMinistry of Trade and IndustryEmtedad Ramses St., Nasr City, Cairo- EgyptEmail: [email protected]: www.tas.gov.egTel.: + 20 (2) 23421950Fax: + 20 (2) 23421946 National Enquiry Point Egyptian Organization for Standardization and Quality16 Tadreeb El-Modarrebeen St., Ameriya, Cairo - EgyptE-mail: [email protected]/[email protected]: http://www.eos.org.egTel: + (202) 22845528 - Fax: + (202) 22845504

Products Covered: • Milk and milk products (except for infants' milk) for retail sale in packages weighing no more than 2 kilograms (Products of HS codes from 04.01 to 04.06) ; • Preserved and dried fruits for retail sale in packages weighing no more than 2 kilograms (Products of HS Chapter 08) ; • Oils and fats for retail sale in packages weighing no more than 5 kilograms (Products of HS chapter 15) ; • Chocolates and food products containing cocoa for retail sale in packages weighing no more than 2 kilograms (Products of HS code 18.06) ; • Sugar confectionaries (HS code 17.04) ; • Pastas and prepared foods from cereals and bread products and pastries except for empty cachets of a kind suitable for pharmaceutical use (HS codes 19.02-19.04-19.05) ; • Fruit juices for retail sale in packages weighing less than 10 kilograms (Products of HS code 20.09) ; • Natural and mineral water and aerated water (HS codes 22.01-22.02) ; • Beauty and make-up products, preparations for oral or dental hygiene, personal deodorants and antiperspirants, and perfumed preparations (HS codes from 33.03 to 33.07 ) ; • Soap and washing preparations used as soap for retail sale (HS 3401.11 – 3401.19 – 3401.2090 – 3401.30 - 3402.20 – 3402.9090) ; • Cutlery and kitchen utensils (HS codes 39.24 - 4419 – 69.11 – 6912 – 73.23 – 7418.10 – 7615.10 – 8211.10 - 8211.91 - 82.15) ; • Baths, shower baths, sinks, washbasins, bidets, lavatory pans, seats and covers ; • Toilet Paper and similar paper, babies and sanitary napkins (HS codes 9619 –48.18 (except for 4818.1090 ) – 4803) ; • Refractory bricks, blocks, tiles for household use (HS codes 6802.10 – 6802.2110 – 6802.9110 – 6904.40 - 6810.19 – 69.07 – 69.08) ; • Tableware glass articles (HS code 70.13) ; • Iron and steel bars and rods (HS codes 72.13 – 72.14 – 72.15) ; • Household electrical appliances (stoves, fryers, air conditioners, fans, washing machines, blenders and heaters) (Products of HS codes 73.21 – 73.22 – 8414.51 - 8415.10 8415.81 - 8415.82 – 8415.83 – 8418.10 – 8418.21 – 8418.29 – 8418.30 – 8418.40 – 8422.11 – 8450.11 – 8450.12 – 8450.19 – 8451.21 – 8508.11 – 8509.40 – 8509.80 – 8516.10 – 8516.21 – 8516.32 – 8516.40 – 8516.50 – 8516.60 – 8516.71 – 8516.72 – 8516.79 – 8527.12 – 8527.13 – 8527.19 – 8527.91 – 8527.92 – 8527.99 – 8528.71 – 8528.7220 – 8528.7290 – 8528.73) ; • Home and Office furniture (HS codes 9401.30 – 9401.40 – 9401.51 – 9401.59 – 9401.61 – 9401.69 – 9401.7190 – 9401.79 - 9401.8090 - 94.03 – 94.04 ) ; • Bicycles, motorcycles and those with auxiliary motors (HS codes 87.11 – 8712) ; • Watches and clocks (Products of HS chapter 91) ; • Lightening equipment for household use (HS codes9405.10 – 9405.20 – 9405.30 - 9405.4090) ; • Toys (HS code 9503) ; • Textiles, clothing, and home textiles (HS chapters and codes: 50.07 – 51.11 – 51.12 – 5113 – 52.08 - 52.09 – 52.10 – 52.11 – 52.12 – 53.09 – 5311 - 54.07 – 54.08 – 55.12 – 55.13 – 55.14 – 55.15 – 55.16 – 58.01 – 58.02 – 58.04 – 58.05 – 58.09 - 5810.1090 – 5810.91 – 5810.92 – 5810.99 , Chapter 60 , Chapter 61 (except 6113.0010 6114.3010 – 6115.10 – 6116.1010), Chapter 62 (except 6210.1010 - 6210.2010 – 6210.3010 – 6210.4010 – 6210.5010 - 6211.3910 – 6211.4910 – 6212.2010 – 6212.9010 – 6216.0010 – 62.17), Chapter 63 (except for 63.07) ; • Carpets , floor and wall coverings from textiles or non- textiles materials (HS chapter 57, HS codes 39.18, 4016.91) ; • Footwear (HS codes 64.01 – 64.02 – 64.03 – 64.04 – 64.05)

Regulation Type: Addendum to Regular Notification

Distribution date: 14 April 2022 | Final date for Comment: 13 June 2022

This document specifies the terms and definitions, classification and marking, requirements, test methods, inspection rules, marking, packaging, transportation and storage of structural silicone sealant for building (hereinafter referred to as structural silicone sealant).This document applies to structural silicone  for bonding and assembly of building curtain wall and other structures with an expected design service life of no less than 25 years.

Products Covered: One component structural silicone  sealant, Two components structural silicone  sealant (HS code(s): 350610, 350691); (ICS code(s): 91.100.50)

Regulation Type: Regular notification

Distribution date: 14 April 2022 | Final date for Comment: 13 June 2022

This document specifies the terms and definitions, classification and marking, requirements, test methods, inspection rules, marking, packaging, transportation and storage of structural silicone sealant for building (hereinafter referred to as structural silicone sealant).This document applies to structural silicone  for bonding and assembly of building curtain wall and other structures with an expected design service life of no less than 25 years.

Products Covered: One component structural silicone  sealant, Two components structural silicone  sealant (HS code(s): 350610, 350691); (ICS code(s): 91.100.50)

Regulation Type: Regular notification

Distribution date: 14 April 2022

This normative instruction contains provisions on an amendment to the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservers, published by Normative Instruction number 103 - 19 October 2021 on the Brazilian Official Gazette (DOU - Diário Oficial da União).

Products Covered: HS Code(s): 52; ICS Code(s): 13

Regulation Type: Regular notification